Current jobs related to Medical Device Regulatory Affairs Manager - Penang - Andaman Medical


  • Penang, Malaysia Ambu AS Full time

    About the RoleWe are looking for a talented Global Regulatory Affairs Manager to lead our regulatory efforts in the medical device industry.This role requires expertise in regulatory affairs, quality assurance, and medical devices.Main Responsibilities:Regulatory StrategyDevelop and implement regulatory strategies to ensure compliance with regional...


  • Penang, Malaysia Ambu AS Full time

    Job SummaryAmbu A/S seeks an experienced Medical Device Regulatory Expert to support our global regulatory efforts.This role involves working closely with cross-functional teams to ensure regulatory compliance and quality assurance.Main Responsibilities:Regulatory IntelligenceStay up-to-date on regional regulations and guidelines applicable to medical...


  • Penang, Malaysia Accuray Asia Ltd Full time

    Regulatory Affairs Specialist, Asia Pacific RegionPenang, MalaysiaPosition Title: Regulatory Affairs Specialist, Asia Pacific RegionWe are seeking a Regulatory Affairs Specialist, Asia Pacific Region who will support obtaining medical device pre-market regulatory approvals to ensure market access for Accuray products and services in Asia Pacific. This...


  • Penang, Malaysia Plexus Corp. Full time

    This role offers an exciting opportunity for a motivated and experienced professional to join Plexus Corp. as a Molding and Tooling Director. As a key member of our team, you will be responsible for overseeing the design, development, and production of plastic components used in medical devices.The ideal candidate will have a strong understanding of medical...


  • Penang, Malaysia Ambu AS Full time

    We are looking for a seasoned Process Improvement Specialist to support our growing Innovation Process Team in Medical Devices. The ideal candidate will have a proven track record of identifying areas for improvement and leading initiatives to enhance efficiency, effectiveness, and compliance within the design control and process framework.The Process...


  • Penang, Malaysia Dawn Medical Technologies Full time

    We are seeking a highly motivated Sales Specialist to join our team at Dawn Medical Technologies. As a Sales Specialist, you will play a crucial role in promoting our medical devices in the healthcare market.Responsibilities:Build strong relationships with healthcare professionals, including surgeons, clinical specialists, and gastroenterologists.Identify...


  • Penang, Malaysia Ambu AS Full time

    Job SummaryAmbu A/S is seeking a talented Head of Medical Device Packaging to lead our packaging development efforts.This role requires a deep understanding of medical device packaging regulatory requirements and a proven track record of developing innovative packaging solutions.Key ResponsibilitiesDevelop and implement comprehensive packaging strategies for...


  • Penang, Malaysia INTEL Full time

    Lead Intel Risk and Control incorporating overall Logistics operation areas via environmental scan and assessment from all aspects. This is inclusive risk radar, classification, and mitigation definition to reduce the risk levels. - Work closely with the Operations Management team to identify, develop, and priorities initiatives that will improve the quality...


  • Penang, Malaysia Plexus Corp. Full time

    We are looking for a highly skilled individual to lead our medical device manufacturing efforts as a Senior Plastics Engineer. The successful candidate will have a bachelor's degree in Mechanical Engineering, Plastics Engineering, or a related field, and at least 10 years of experience in plastic injection molding.Key responsibilities include managing a team...


  • Penang, Malaysia Ambu AS Full time

    About UsAmbu A/S is a leading manufacturer of single-use endoscopy, anesthesia, and patient monitoring solutions.We are seeking a talented Packaging Engineer to join our R&D team and contribute to the development of innovative packaging solutions.Job ResponsibilitiesDesign and develop product packaging by using inventor or equivalent CAD software for the new...


  • Penang, Malaysia Ambu AS Full time

    Ambu A/S is seeking a highly skilled Medical Device Design Control Expert to join our Innovation Process Team. As a key member of this team, you will play a critical role in ensuring the design control processes are compliant with regulatory requirements such as FDA and ISO.The successful candidate will have experience in creating and implementing...

  • Molding Manager

    3 weeks ago


    Penang, Malaysia Plexus Corp. Full time

    A Plastic Molding Engineering Manager in the medical device industry is responsible for overseeing the design, development, and production of plastic components used in medical devices. This role requires a deep understanding of medical device regulations, quality control standards, and the specific requirements of the medical industry.Key...


  • Penang, Malaysia Johnson & Johnson Full time

    About the OpportunityWe are seeking a Sales Executive to join our team in Penang. As a Sales Executive, you will be responsible for driving sales growth and expanding our customer base.ResponsibilitiesMakes regular visits to customer locations to gather information on orders and market conditions.Performs contract and/or tender management activities.Targets...


  • Penang, Malaysia Rapha Medical Sdn Bhd Full time

    **Responsibilities**: - Responsible for the sales and marketing of healthcare products & medical devices - Maintain and strengthen relationship with existing customers - To generate sales leads and secure new accounts - Liaison with local and overseas distributors - Provide inputs to and execute annual marketing and training agenda **Job Requirements**: -...


  • Penang, Malaysia Ambu AS Full time

    Job DescriptionAmbu Global Hub is seeking a highly skilled Regulatory Compliance Specialist to join our Global Emerging Market (GEM) team in Penang, Malaysia.This role is responsible for ensuring regulatory compliance and quality assurance in the medical device industry.Main Responsibilities:Regulatory ComplianceCapture and coordinate information, prepare...


  • Penang, Malaysia Ambu AS Full time

    We are a dynamic and fast-growing workplace with a focus on the person, not just the job. We offer a wide range of exciting job challenges, social activities, and continuous professional and personal development.We are seeking a Quality Software Engineer for Medical Devices to join our team. In this role, you will play a key part in developing and...


  • Penang, Malaysia Ambu AS Full time

    We are looking for a detail-oriented and highly organized Regulatory Compliance Specialist to join our Innovation Process Team. The successful candidate will have a strong understanding of industry regulations, experience in creating and implementing procedures, and a proven ability to ensure compliance with regulatory requirements.The Regulatory Compliance...

  • In-House Counsel

    6 days ago


    Penang, Malaysia Mufg Investorservices Full time

    What You Will DoSupport the business in performing its key function of servicing the legal and regulatory needs of the global business.Work closely with external legal counsel, where required, to advise senior management and to generally support all business functions.Assist the business with managing legal risk and providing strategic legal advice to senior...


  • Penang, Malaysia Ambu Full time

    Business Area: R&D- Employment type: Full-timeDo you have solid knowledge about medical device development? Can you manage the complexity of coordinating and aligning with medical, technical, quality, regulatory and commercial stakeholders? And do you have experience conducting scientific literature review and writing Clinical Evaluation Reports? Then Ambu...


  • Penang, Malaysia Dream Medical Full time

    Dream Medical is proud to announce an exciting opportunity for a medical specialist to join our team as a locum practice nurse at the Ministry of Defence's base in Tidworth. As a key member of our team, you will have the chance to work within the MOD nationwide and contribute to the delivery of exceptional patient care.About the RoleWe are seeking a...

Medical Device Regulatory Affairs Manager

2 weeks ago


Penang, Malaysia Andaman Medical Full time
About Andaman Medical

Andaman Medical is a medical equipment manufacturing company that requires a highly skilled Legal Counsel to oversee its legal operations and corporate affairs.

The ideal candidate will have a strong background in business and corporate law, with excellent leadership, organisational, and management skills.

This role will involve assessing and mitigating legal risks, handling legal documentation, managing corporate secretarial duties, and offering insights and recommendations to guide business decisions.

Key Responsibilities

  • Understand business objectives and explain legal risks to management
  • Help management make informed decisions using both business and legal analysis
  • Review agreements and participate in discussions with external parties
  • Prepare and draft agreements for management approval
  • Handle all company legal matters, including managing difficult client situations
  • Create procedures for legal functions
  • Research laws and regulations, assess risks of agreements with different governing laws, and stay updated on legislation changes
  • Support various projects from risk management and legal perspectives